NCT06311695

Contrast-Enhanced Spectral Mammography (CESM)

The Role of Contrast-Enhanced Spectral Mammography (CESM) in the Diagnostic Process of Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 263 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB).

Detailed description

Breast cancer is the most diagnosed cancer in women and is one of the leading causes of morbidity and death from malignancy. Improvement in survival and quality of life of patients with breast malignancies depends on the ability of imaging to diagnose the neoplasm in its early stages. The main focus of imaging applied to the study of the breast is to obtain a good balance between the number of false positives and false negatives in the prediction of malignancy: good diagnostic performance should be achieved in identifying even small and insidious neoplasms without requiring excessive examinations for benign findings. The main diagnostic method of screening for breast malignancy still remains mammography also considering its quick execution and low cost: however as is well known the diagnostic performance of mammography is highly impaired, in patients with dense breasts. The reduced sensitivity of mammography in women with dense breasts can result in a significant underdiagnosis rate, failing to prevent death due to breast cancer in a non-negligible number of women. The sensitivity of mammography is reported in the literature as between 62-68% in dense breasts: such performance is far too low to ensure adequate support in the management of breast malignancy; supplemental screening should be recommended in women with dense breasts. For this purpose, a diagnostic technique called contrast-enhanced mammography (CEM) has been developed in recent years: CEM is based on the use of an iodinated contrast medium to assess the vascularity of any breast lesions and its first use was approved in 2011 by the food and drug administration (FDA). The diagnostic performance of CEM in detecting and predicting the malignancy of breast lesions has been evaluated in many studies that have shown very promising result: CEM seems to provide excellent performance, particularly where conventional diagnostic methods seem to be struggling: the low sensitivity of mammography in dense breasts; the high operator dependence of breast ultrasound; the high cost, the high number of false positives and the time required to perform Magnetic Resonance Imaging (MRI). The purpose of this studt is to assess the diagnostic performance of recombined CEM image, in predicting malignancy of breast lesions in a population mainly represented by patients with dense breasts.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Contrast Enhanced Mammography	Contrast Enhanced Mammography

Timeline

• Start date: 2020-11-16
• Primary completion: 2025-02-28
• Completion: 2025-12-31
• First posted: 2024-03-15
• Last updated: 2024-06-24

Locations

1 site across 1 country: Italy